title: Phase II trial of pemetrexed-based induction chemotherapy followed by concomitant chemoradiotherapy in previously irradiated patients with squamous cell carcinoma of the head and neck.
abstract: BACKGROUND
  Concurrent chemoreirradiation therapy (CRRT) offers a therapeutic option for patients with locoregionally recurrent squamous cell carcinoma of the head and neck (SCCHN). We hypothesized that response to induction chemotherapy (IC) would improve outcome and predict increased survival.
  
  
  METHODS
  Subjects with recurrent SCCHN not amenable to standard therapy were eligible. IC consisted of two 28-day cycles of gemcitabine and pemetrexed on days 1 and 14, followed by surgical resection, if appropriate, and/or CRRT consisting of carboplatin, pemetrexed, and single daily fractionated radiotherapy.
  
  
  RESULTS
  Thirty-five subjects were enrolled, 31 were assessable for response, with 11 responders [response rate = 35%; 95% confidence interval (CI) 19.2-54.6]. Among 24 subjects who started CRRT, 11 were assessable for radiographic response, 4 complete response, 2 partial response, and 5 progressive disease. Median progression-free survival and overall survival (OS) were 5.5 months (95% CI 3.6-8.3) and 9.5 months (95% CI 7.2-15.4), respectively. One-year OS was 43% (95% CI 26% to 58%). Subjects who responded to IC had improved survival (P = 0.02). Toxic effects included mucositis, dermatitis, neutropenia, infection, hemorrhage, dehydration, and pain.
  
  
  CONCLUSIONS
  The combination of pemetrexed plus gemcitabine was active and well tolerated in recurrent SCCHN. Response to IC may help stratify prognosis and offer an objective and dynamic metric in recurrent SCCHN patients being considered for CRRT.
authors.affiliation: Department of Medicine, Section of Hematology/Oncology.
authors.forename: V M
authors.initials: VM
authors.lastname: Villaflor
authors.affiliation: Department of Radiation Oncology, University of Chicago, Chicago.
authors.forename: D
authors.initials: D
authors.lastname: Haraf
authors.affiliation: Department of Radiation Oncology, University of Chicago, Chicago; Department of Radiation Oncology, Duke University, Durham.
authors.forename: J K
authors.initials: JK
authors.lastname: Salama
authors.affiliation: Department of Health Studies, University of Chicago, Chicago.
authors.forename: M
authors.initials: M
authors.lastname: Kocherginsky
authors.affiliation: Department of Surgery, Section of Otolaryngology Head and Neck Surgery, University of Chicago, Chicago, USA.
authors.forename: A
authors.initials: A
authors.lastname: Langerman
authors.affiliation: Department of Medical Oncology, Hospital Aleman, Buenos Aires, Argentina.
authors.forename: G
authors.initials: G
authors.lastname: Gomez-Abuin
authors.affiliation: Department of Medicine, University of Chicago, Chicago, USA.
authors.forename: P
authors.initials: P
authors.lastname: Beniwal
authors.affiliation: Department of Surgery, Section of Otolaryngology Head and Neck Surgery, University of Chicago, Chicago, USA.
authors.forename: E A
authors.initials: EA
authors.lastname: Blair
authors.affiliation: Department of Surgery, Section of Otolaryngology Head and Neck Surgery, University of Chicago, Chicago, USA.
authors.forename: K M
authors.initials: KM
authors.lastname: Stenson
authors.affiliation: Department of Surgery, Section of Otolaryngology Head and Neck Surgery, University of Chicago, Chicago, USA.
authors.forename: L
authors.initials: L
authors.lastname: Portugal
authors.affiliation: Department of Medicine, Section of Hematology/Oncology.
authors.forename: T
authors.initials: T
authors.lastname: Seiwert
authors.affiliation: Department of Medicine, Section of Hematology/Oncology.
authors.forename: R D
authors.initials: RD
authors.lastname: Williams
authors.affiliation: Department of Medicine, Section of Hematology/Oncology.
authors.forename: A J
authors.initials: AJ
authors.lastname: Dekker
authors.affiliation: Department of Radiation Oncology, University of Chicago, Chicago.
authors.forename: M E
authors.initials: ME
authors.lastname: Witt
authors.affiliation: Department of Medicine, Section of Hematology/Oncology; Department of Radiation Oncology, University of Chicago, Chicago.
authors.forename: E E
authors.initials: EE
authors.lastname: Vokes
authors.affiliation: Department of Medicine, Section of Hematology/Oncology. Electronic address: ecohen@medicine.bsd.uchicago.edu.
authors.forename: E E W
authors.initials: EEW
authors.lastname: Cohen
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D003131:Combined Modality Therapy / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D005971:Glutamates / Q000008:administration & dosage / Q000009:adverse effects; D006147:Guanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D006801:Humans; D060828:Induction Chemotherapy; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000532:radiotherapy*; D000068437:Pemetrexed; D011446:Prospective Studies; D011878:Radiotherapy / Q000009:adverse effects; D000077195:Squamous Cell Carcinoma of Head and Neck; D000093542:Gemcitabine
chemical_list: D005971:Glutamates; D000068437:Pemetrexed; D003841:Deoxycytidine; D006147:Guanine; D000093542:Gemcitabine